- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04305197
A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)
November 28, 2022 updated by: Beijing InnoCare Pharma Tech Co., Ltd.
A Phase Ib/IIa Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerance, Pharmacokinetics/ Pharmacodynamics(PK/PD) of ICP-022 in Patients With Mild and Moderate Systemic Lupus Erythematosus
The purpose of the study is to assess the Safety, Tolerability, PK/PD and preliminary Efficacy of ICP-022 in Subjects with Systemic Lupus Erythematosus (SLE)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Anhui
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Bengbu, Anhui, China
- The First Affiliated Hospital of Bengbu Medical College
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Beijing
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Beijing, Beijing, China, 100000
- Peking University Third Hospital
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Beijing, Beijing, China, 100000
- Peking University People's Hospital
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Guangdong
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Guangzhou, Guangdong, China
- Guangdong General Hospital
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Shenzhen, Guangdong, China
- ShenZhen People's Hospital
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Shenzhen, Guangdong, China
- University of Hong Kong shenzhen hospital
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Henan
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Zhengzhou, Henan, China
- First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, China
- Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
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-
Jiangsu
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Nanjing, Jiangsu, China, 210000
- Gulou Hospital Affiliated to Medical College of Nanjing University
-
-
Shanghai
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Shanghai, Shanghai, China
- Huashan Hospital affiliated to Fudan University
-
-
Shanxi
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Taiyuan, Shanxi, China
- The First Affiliated Hospital of Shanxi Medical University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects aged 18 to 75
- diagnosis of with SLE at least 6 months at screening visit
- SLEDAE-2K≥5
- Is receiving standard treatment for SLE and has been receiving treatment for at least 3 months.
- At least one SLE activity manifestation (as assessed by SLEDAE-2K)
Exclusion Criteria:
- Failure to comply with the requirements of the programme
- A female or male partner who is pregnant or breastfeeding or who plans to become pregnant during the study period
- Previously treated with a BTK inhibitor
- Neuropsychiatric lupus (NPSLE)
- Has other autoimmune diseases other than SLE
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period
|
Experimental: Medium Dose
|
Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
|
Experimental: Lower Dose
|
Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
|
Experimental: Higher Dose
|
Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 28 Days after the last dose of study drug
|
Up to 28 Days after the last dose of study drug
|
Number of Patients with Treatment-emergent Adverse Event(TEAEs) according to severity
Time Frame: Up to 28 Days after the last dose of study drug
|
Up to 28 Days after the last dose of study drug
|
Number of participants with clinically significant physical examination abnormalities
Time Frame: Up to 28 Days after the last dose of study drug
|
Up to 28 Days after the last dose of study drug
|
Number of participants with clinically significant vital signs abnormalities
Time Frame: Up to 28 Days after the last dose of study drug
|
Up to 28 Days after the last dose of study drug
|
Number of participants with clinically significant ECG abnormalities
Time Frame: Up to 28 Days after the last dose of study drug
|
Up to 28 Days after the last dose of study drug
|
Number of participants with clinically significant laboratory examination abnormalities
Time Frame: Up to 28 Days after the last dose of study drug
|
Up to 28 Days after the last dose of study drug
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4)
Time Frame: 12 Weeks
|
12 Weeks
|
|
Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6)
Time Frame: 12 Weeks
|
12 Weeks
|
|
Occupancy rate of Bruton Tyrosine Kinase(BTK)
Time Frame: 14 Days
|
14 Days
|
|
Serum Immunoglobulin (Ig) level
Time Frame: 12 Weeks
|
12 Weeks
|
|
Changes from Baseline in Ig levels
Time Frame: 12 Weeks
|
12 Weeks
|
|
Changes from Baseline in C3
Time Frame: 12 Weeks
|
12 Weeks
|
|
Changes from Baseline in C4
Time Frame: 12 Weeks
|
12 Weeks
|
|
Changes from Baseline in serum dsDNA
Time Frame: 12 Weeks
|
12 Weeks
|
|
Changes from Baseline in Anti-nuclear Antibodies
Time Frame: 12 Weeks
|
12 Weeks
|
|
Changes from Baseline in Interferon-α(INF-α) level
Time Frame: 12 Weeks
|
Changes from Baseline in cytokine levels
|
12 Weeks
|
Changes from Baseline in Interleukin-6(IL-6) level
Time Frame: 12 Weeks
|
Changes from Baseline in cytokine levels
|
12 Weeks
|
Changes from Baseline in total B cell counts
Time Frame: 12 Weeks
|
12 Weeks
|
|
Change from Baseline in Beffs count
Time Frame: 12 Weeks
|
12 Weeks
|
|
Changes from baseline in Bregs count
Time Frame: 12 Weeks
|
12 Weeks
|
|
Changes from Baseline in Bregs to Beffs ratio
Time Frame: 12 Weeks
|
12 Weeks
|
|
Changes from Baseline in Erythrocyte Sedimentation Rate(ESR)
Time Frame: 12 Weeks
|
12 Weeks
|
|
The plasma concentration-time curve
Time Frame: 14 Days
|
14 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zhanguo Li, MD/PhD, Peking University People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 9, 2020
Primary Completion (Actual)
April 28, 2022
Study Completion (Actual)
April 28, 2022
Study Registration Dates
First Submitted
March 10, 2020
First Submitted That Met QC Criteria
March 10, 2020
First Posted (Actual)
March 12, 2020
Study Record Updates
Last Update Posted (Actual)
November 30, 2022
Last Update Submitted That Met QC Criteria
November 28, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICP-CL-00109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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